Industry news
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In wake of biopharma mega buyouts, FTC kicks off review of industry's dealmaking
18 March 2021
These are three of the biggest pharma mergers of the past couple years. They're also the kind of deals the Biden administration's Federal Trade Commission (FTC) might have scrutinized more closely, an agency official said Tuesday in announcing a sweeping review of its approach to biopharma M&A.
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Dissecting the impact of COVID-19 on pharmaceutical regulatory practices
18 March 2021
In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
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Meeting the challenge to deliver COVID-19 relief around the world
17 March 2021
Each challenge COVID-19 has presented in the past year has seemed insurmountable yet at every step those obstacles have been overcome, particularly in the pharmaceutical industry tasked with developing vaccines and therapies to combat this crisis.
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How the gut microbiome is inspiring new approaches to treating brain disorders
17 March 2021
In recent years, abnormalities in the gut microbiome have been tied to a range of neurological disorders, including multiple sclerosis and Parkinson’s disease. Now, researchers at Baylor College of Medicine have preclinical evidence that some symptoms caused by complex brain diseases might be able to be treated with microbe-based therapies like probiotics.
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Immune response research shows GM-CSF plays role in COVID-19 severity
16 March 2021
The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza.
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Keeping momentum in the life sciences sector
16 March 2021
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
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FDA calls meeting to weigh quick cancer approvals
15 March 2021
As part of an industry-wide review, the FDA persuaded PD-1/L1 players Merck & Co., Bristol Myers Squibb, Roche and AstraZeneca to remove four indications on the labels of cancer drugs, after the failure of post-marketing studies. But the agency wasn’t so sure about six others, so it’s calling for some external input.
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There’s A New Coil In Town, So What’s The Deal?
15 March 2021
The Ballerine IUB (intrauterine ball) was developed by OCON Medical and launched in Austria in 2014. Much of Europe has had the IUB as an option for years and it’s also available in parts of Africa and the Middle East. Meanwhile, in the UK, it’s been available privately since March 2017. It was originally due to be rolled out on the NHS in 2020 but – like so many things – coronavirus stopped it in its tracks.
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Could Diphtheria Become Resistant to Vaccines?
12 March 2021
Diphtheria could once again become a major global health problem due to vaccine and antibiotic resistance, researchers warn. Diphtheria is a highly contagious -- and potentially deadly -- infection that can affect the nose and throat, as well as the skin.
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WTO addresses vaccine supply, export restrictions
12 March 2021
With COVID-19 vaccine manufacturing still scaling up and the scarcity of some supplies, most of the vaccine doses available so far have been distributed in 75 countries while 115 countries are still waiting, World Trade Organization (WTO) Director-General Ngozi Okonjo-Iweala said at the March 9 Global C19 Vaccine Supply Chain and Manufacturing Summit.
